Sunmark Junior Rapid Melts
FDA Label NDC 49348-063

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Sunmark Junior Rapid Melts (NDC 49348-063). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.

Do Not Use

  • with any other product containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition

    Keep out of reach of children.

    Overdose warning: Thaking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult dose
  • do not give more than directed (see overdose warning)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth, or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
    •  Weight (lb) Age (yr) Tablets
     under 48 lbs under 6 years ask a doctor
     48-59 lbs 6-8 years 2
     60-71 lbs 9-10 years 2 1/2
     72-95 lbs 11 years 3

Other Information

  • store at controlled room temperature betweeen 20-25oC(68-77oF)
  • see end flap for expiration date and lot number

Inactive Ingredients

acesulfame pottasium, citric acid, D&C red 27 aluminum lake, dextrose, FD&C blue 1 aluminum lake, flavors, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose powder, polyplasdone, sorbitol, sucralose.

May contain ethylcellulose, gelatin, sodium polyphosphate, silicon dioxide.

Pdp

Sunmark

Junior Rapid Melts

Compare to JR. Tylenol Meltaways active ingredient

Pain reliever

Fever reducer

Acetaminophen

Pain reliever/Fever Reducer

For ages 6-11 years

Bubblegum Flavor

24 Tablets

Box (Sm220)

Box (Sm220)

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